RCC Nanotechnology Policy Principles for Decision-Making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials (PDF; 31 KB)

Prime Minister Harper and President Obama created the Canada-US Regulatory Cooperation Council (RCC) in February 2011 to increase regulatory transparency and coordination between the two countries.  The RCC Joint Action Plan[1  is an important step in the ongoing process of regulatory cooperation between Canada and the United States.  It addresses four key sectors encompassing 29 initiatives in total, including nanotechnology[2]

Regulation plays an important role in both our countries. While our regulatory systems are very similar in the objectives they seek to achieve, differences can occur.  So there is value in enhancing mechanisms to foster cooperation in designing regulations and to ensure alignment in their implementation and enforcement.  This will provide consumer and environmental protection and facilitate cross-border trade and the promotion of innovation between both countries. Unnecessary regulatory differences and duplicative actions hinder cross-border trade and investment and ultimately impose a cost on our citizens, businesses and economies.

The goal under the RCC nanotechnology workplan is to promote the development of common approaches, to the extent possible, on key regulatory elements for nanomaterials, including approaches to risk assessment and management,  criteria for determining characteristics of regulatory concern/no concern, and information gathering2.

Under the RCC nanotechnology workplan, Canada has committed to considering the US document “Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials” (US Document henceforth) and subsequently, wherever appropriate, develop shared and/or common principles to guide Departments and Agencies in their oversight of nanomaterials.

While no Government of Canada wide definitions for nanomaterials and nanotechnology currently exist, for the purposes of this document, the Health Canada working definition of nanomaterials [3] is used. This working definition, indicates that a manufactured substance or product and any component material, ingredient, device, or structure is considered to be a nanomaterial if “(a) it is at or within the nanoscale (1-100nm) in at least one external dimension or has internal or surface structure at the nanoscale; or  (b) it is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale/properties/phenomena”. Nanotechnology is described as the control of matter at the nanoscale or utilizing nanoscale phenomena to enable novel applications.

The above definition and description of nanotechnology are consistent with those described in the US Document [4].

Nanomaterials and nano-enabled products continue to enter the Canadian marketplace in a variety of sectors including information technology, aerospace, energy, medicine and transportation – affecting various aspects of our daily lives. Examples of current nanotechnology applications include more efficient semiconductors, scratch resistant coatings, and enhanced pharmaceuticals, while potential applications include smart anticancer therapeutics and the next breakthrough in computing. While recognizing the potential economic and societal benefits of nanomaterials, it is important to ensure they are used safely and that their potential risks to the environment and human health are well understood and managed.

The Government of Canada actively invests in research and development associated with nanotechnologies. Government, academic, and industry partnerships are leading to increases in nano-enabled products entering our marketplace. A key example of such a partnership is the establishment of the National Institute of Nanotechnology which provides state-of-the-art research and development support for companies bringing products into the marketplace. In addition, the Government of Canada continues to support environmental, health and safety research on nanomaterials, which contributes to our understanding of the fate and effects of nanomaterials in the environment and to human health.

The Government of Canada uses existing policies and regulatory frameworks to evaluate the potential risks to human health and the environment from nanomaterials. In regulating nanomaterials, federal departments rely on the best available scientific and technical information to address the unique properties and behaviours associated with nanomaterials and their applications.

In 2007, the Government of Canada asked the Council of Canadian Academies (CCA) to assess the state of knowledge regarding the risks of nanomaterials and whether these risks might have an effect on the regulations which support research, risk assessment, and surveillance. In response, the CCA established an Expert Panel on Nanotechnology. In its report [5], it acknowledged that while it is not necessary to create new regulatory mechanisms in Canada to address the unique challenges presented by nanomaterials, there is an ongoing need to invest in strategic research, classification, regulatory triggers and capacity. It also stated that regulatory agencies should coordinate their activities with each other, between federal and provincial levels of government and with the regulatory agencies of other countries.

The Government of Canada led a multi-departmental and agency consensus-based process which included reviewing the existing US principles to determine if there was alignment and agreement with existing Canadian policies, laws and statutes and determine the existence of any gaps. Overall, the US Principles were found to be in agreement with existing Canadian programs related to nanomaterials. In addition, it was found that the Principles were balanced in that they promoted scientific capacity-building to increase regulatory certainty while supporting economic growth. Below are a list of Policy Principles for oversight of nanomaterials and nanotechnology, derived from the US document, that are supported by the Government of Canada. These Principles build on the foundation provided by current regulatory statutes and do not supersede existing legal authorities or hinder federal departments and agencies from enforcing or applying their existing statutory and regulatory authority as mandated by law. 

Policy Principles for Decision-Making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials:

•    To ensure scientific integrity, base decisions on the best available scientific evidence, acknowledging policy considerations to the extent feasible;

•    Seek and develop adequate information with respect to the potential effects of nanomaterials on human health and the environment and take into account new knowledge when it becomes available;

•    To the extent feasible and subject to valid constraints (involving, for example, confidential business information), develop relevant information in an open and transparent manner, with opportunities for stakeholder involvement and public participation;

•    Communicate information to the public regarding the potential benefits and risks associated with specific uses of nanomaterials;

•    Base decisions on an awareness of the potential benefits and the potential costs of such regulation and oversight, including recognition of the role of limited information and risk in decision making;

•    To the extent practicable, provide sufficient flexibility in oversight and regulation to accommodate new evidence and learning on nanomaterials;

•    Consistent with current statutes and regulations, strive to reach an appropriate level of consistency in risk assessment and risk management across the Government of Canada, using standard oversight approaches to assess risks and benefits and manage risks, considering safety, health and environmental impacts, and exposure mitigation;

•    Mandate risk management actions appropriate to, and commensurate with, the degree of risk identified in an assessment;

•    Seek to coordinate among federal departments, and with stakeholders to address the breadth of issues, including potential health and safety, economic, environmental, and ethical issues associated with nanomaterials; and

•    Encourage coordinated and collaborative research across the international community and clearly communicate the regulatory approaches and understanding of Canada to other nations.

These policy principles are completely consistent with those of the U.S. Government as released in the June 2011 document [6]

The Government of Canada will continue to foster innovation associated with nanomaterials and nanotechnology, while protecting Canadians and their environment. It is expected that federal programs will consider the principles described herein while implementing their areas of regulatory responsibility for the oversight of nanomaterials and nanotechnology and that the assessment and management of nanomaterials will continue to be evidence-based and application-specific as appropriate under the applicable programs.

[3] “Policy Statement on Health Canada’s Working Definition for Nanomaterial” available in English at: http://www.hc-sc.gc.ca/sr-sr/pubs/nano/pol-eng.php and French at http://www.hc-sc.gc.ca/sr-sr/pubs/nano/pol-fra.php

[4]National Nanotechnology Initiative Website:http://www.nano.gov/nanotech-101/what/definition